DeviceClearance

Product code OEH— Microbiology

JBAIDS TULAREMIA DETECTION KIT

Classification name
Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
Device class
Class 2
Regulation
21 CFR 866.3280
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification definition

“To aid in the diagnosis of individuals presenting with signs and symptoms of pneumonic or typhoidal tularemia with a qualitative in vitro diagnostic (ivd) detection of target dna sequences of francisella tularensis.”

— U.S. Food and Drug Administration, device classification record for product code OEH under 21 CFR 866.3280, via openFDA

Market context for product code OEH

FDA has cleared 2 devices under product code OEH between 2007 and 2013, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OEH

Recent clearances under product code OEH

Data sourced from openFDA. This site is unofficial and independent of the FDA.